Emory Cardiac Toolbox

The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion…

Registry build 21.09.26

The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parameters of left-ventricular perfusion and function from gated SPECT & PET myocardial perfusion studies and for the evaluation of dynamic PET studies. These parameters are: perfusion, ejection fraction, end-diastolic volume, end-systolic volume, myocardial mass, transient ischemic dilatation (TID), analysis of coronary blood flow and coronary flow reserve, and assessment of cardiac mechanic dyssynchrony. In addition, the program offers the capability of providing the following diagnostic information: computer assisted visual scoring, prognostic information, and expert system image interpretation. The program can also be used for the 3D alignment of coronary artery models from CT coronary angiography onto the left ventricular 3D epicardial surface and for generation of the short axis, vertical, and horizontal long axis tomograms from the SPECT raw data using either filtered backprojection (FBP) or iterative reconstruction (MLEM/OSEM). The Emory Cardiac Toolbox can be used with any of the following Myocardial SPECT Protocols: Same Day and Two Day Sestamibi, Dual-Isotope (Tc-99m/Tl-201), Tetrofosmin, and Thallium, Rubidium-82, Rubidium-82 with CT-based attenuation correction, N-13-ammonia, FDG protocols, and user defined normal databases. This program was developed to run in the.NET operating system environment which can be executed on any PC, any nuclear medicine computer system, or through a web browser. In addition, the program can be used for the decision support in interpretation and automatic structured reporting of the study. The program processes the studies automatically, however, user verification of output is required and manual processing capability is provided.

4manufacturers in China registered for this device type
10catalogue numbers in this listing
13510(k) clearances naming this product code

Who Else Makes It

Concentrated in Beijing (1), Shanghai (1), Guangdong (1).

Chinese manufacturers registered for FDA product code KPS
Manufacturer City Province Registered as Device types
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
Shanghai United Imaging Healthcare Co., Ltd. Shanghai Shanghai Manufacturer 12
Siemens Shenzhen Magnetic Resonance Ltd. Shenzhen Guangdong Contract manufacturer 8
Neusoft Positron Medical Systems Co., Ltd. Shen Yang Liaoning Manufacturer 1

Record

Regulatory record for Emory Cardiac Toolbox
Listed by Syntermed, Inc., United States
FDA product code KPS
Device type System, Tomography, Computed, Emission
Device class Class 2
Regulation 21 CFR 892.1200
Establishment Specification developer, Repacker / relabeller, Manufacturer
510(k) K123646
Record published 2025-03-26
Record revised 2018-07-06 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Emory Cardiac Toolbox
Catalogue number Size Status
4.2.9214.18548 In distribution
4.2.7559.13747 In distribution
4.0.5121.18001 In distribution
4.27720.29473 In distribution
4.2.9312.29770 In distribution
4.27720.29473 In distribution
4.2.8339.22556 In distribution
4.2.7003.28586 In distribution
4.28706.22036 In distribution
4.2.8851.24480 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
NeuroQ Syntermed, Inc. 11
Discovery GE Medical Systems, L.L.C. 7
uMI Shanghai United Imaging Healthcare Co., Ltd. 7
Brightonix Brightonix Imaging Inc. 6
UltraSPECT Ultraspect USA, LLC 5
Discovery G E Medical Systems Israel Ltd. 5
Veriton CT Spectrum Dynamics Medical Ltd. 5
Cardius 2 Digirad Corp. 4
Encompass™ SRS Fibreplast™ System Qfix 4
Veriton NM Spectrum Dynamics Medical Ltd. 3
Cedars-Sinai Cardiac Suite Cedars Sinai Medical Center 3
Affinity Hermes Medical Solutions, AB 3

Showing 12 of 172. All products under System, Tomography, Computed, Emission

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K223422 2023-03-30
K180077 2018-08-16
K130902 2013-06-14
K130451 2013-05-17
K123646 2013-02-22
K072307 2008-03-14
K071503 2007-07-26
K042258 2004-10-04
K041022 2004-06-17
K040141 2004-01-30
K020300 2002-04-23
K014033 2002-02-22
K001276 2000-07-17

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer